Amyotrophic Lateral SclerosisPhase 2NCT01569958
Transcranial Direct Current Stimulation as a Novel Therapeutic Approach in Amyotrophic Lateral Sclerosis
A Phase 2 study testing transcranial direct current stimulation in people with Amyotrophic Lateral Sclerosis, run by Università degli Studi 'G. d'Annunzio' Chieti e Pescara at 3 sites in Italy.
Trial summary
Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disease characterized by progressive weakness and muscular atrophy due to the degeneration and loss of motor neurons, the nerve cells that, in the central nervous system (motor cortex, brainstem and spinal chord), control voluntary movement. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- transcranial direct current stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 3 sitesItaly
- Study dates
- Jul 2012to Apr 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of probable, laboratory-supported probable, or definite amyotrophic lateral sclerosis according to the El Escorial revised criteria
- spinal onset
- aged 18 to 85 years inclusive
- disease duration ≤ 24 months
- disease progression in the past 3 months
- FVC ≥ 70% of predicted
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- score ≥ 2 at the item "swallowing"of the ALS Functional Rating Scale Revised
- score ≥ 2 at the item "walking"of the ALS Functional Rating Scale Revised
- in treatment with steady regimen of riluzole for a minimum of 1 month before study entry, and desiring its continuation
- able to give informed consent
- written informed consent
Who cannot join
- bulbar onset
- previous poliomyelitis
- motor neuron diseases other than ALS
- clinical involvement of other neurological systems
- pregnancy, lactation,or unwillingness to contraception if required
- possible contraindications to tDCS: metals in the head (excluding the mouth); electromedical devices; seizures; drugs or neurological conditions lowering seizure threshold; alcoholism; severe heart diseases
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- any severe disease other than ALS
- experimental drugs within 1 month prior to enrollment
- drugs potentially modifying the response to tDCS
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 3 recruiting
- Recruiting
Centro Regionale Malattie Neuromuscolari, Ospedale Clinicizzato "SS. Annunziata"
Chieti, Chieti, 66013
Margherita Capasso, MD, PhD, 00390871358585, neurolab@unich.it
Alessandra Lugaresi, MD, PhD
- Not yet recruiting
Azienda Policlinico Università Federico II
Naples, Napoli, 80131
Lucio Santoro, MD
- Not yet recruiting
Policlinico Universitario Agostino Gemelli
Rome, Rome, 00168
Vincenzo Di Lazzaro, MD
About this study
Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disease characterized by progressive weakness and muscular atrophy due to the degeneration and loss of motor neurons, the nerve cells that, in the central nervous system (motor cortex, brainstem and spinal chord), control voluntary movement. Riluzole, the only drug approved for ALS treatment, modestly slow disease progression.
Transcranial direct current stimulation (tDCS) is a noninvasive technique of neuromodulation that is currently studied as a possible therapeutic tool for several neurological and psychiatric diseases and has been found safe and well tolerated. Based on experimental evidence in animals and human subjects, tDCS is expected to reduce motor cortex excitability and excitotoxicity, that is neuronal injury induced by excessive glutamatergic stimulation, one of postulated pathophysiological mechanisms in ALS.
This study will investigate if transcranial direct current stimulation of motor cortex is useful in delaying disease progression and is well tolerated in ALS patients.
Read the detailed description
This is a double blind, randomized, placebo-controlled clinical trial.
Cathodic tDCS (1 mA for 20 minutes) will be sequentially applied over the motor cortex of both sides, for five consecutive days every month for twelve months. The control group will receive a sham stimulation that reproduce tactile sensation of real stimulation but has no effects on central nervous system. For stimulation, researchers will employ a CE-certified medical device acting as a micro-processor-controlled constant current source. All patients will take riluzole during the entire period of the study.
Fifty-four participants will be recruited from three Italian Centers and randomized to one of two arms of the study.
Disease progression and quality of life will be evaluated at baseline and every three months during the study.
At each visit adverse events will be reported and tolerability will be assessed through a specific questionnaire.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- transcranial direct current stimulation, Sham stimulation
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationOther
transcranial direct current stimulation applied to the motor cortex of both sides (1 mA, 20 minutes) for five consecutive days every month for 12 months
Sham stimulationOther
1 mA stimulation for 30 seconds every 900 seconds per session
| Study group | Role | What they receive |
|---|---|---|
| tDCS | Active comparator | Not described Receives: Other: transcranial direct current stimulation |
| sham | Sham comparator | Not described Receives: Other: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decline of ALSFRS-R (ALS functional rating scale-revised) from baseline to 12 months
Measured: 12 months
Secondary outcomes (4)
Decline of muscle strength from baseline to 12 months
A megascore will be obtained by summing scores of single muscles manually tested according to the Medical Research Council Scale
Measured: 12 months
Change of upper motor neuron signs from baseline to 12 months
A score will be obtained based on presence/absence of listed upper motor neuron signs and grade of spasticity
Measured: 12 months
Decline of forced vital capacity (percent of predicted normal) from baseline to 12 months
Measured: 12 months
Change of quality of life from baseline to 12 months
The ALSAQ-40 questionnaire will be employed
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi 'G. d'Annunzio' Chieti e Pescara
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic University, Italy, Federico II University, Ministero della Salute, Italy
- Responsible party
- Principal investigator, Alessandra Lugaresi, Università degli Studi 'G. d'Annunzio' Chieti e Pescara
- Investigators
- Alessandra Lugaresi, MD, PhD, Principal investigator, Università "G. d'Annunzio" di Chieti e Pescara, Dipartimento Neuroscienze ed Imaging, and ASL n. 2 Lanciano-Vasto-Chieti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569958
- Sponsor's protocol ID
- TDCS2011-01
- Other IDs
- RF-ABR-2007-631680
- Status last verified
- Oct 2012
- First submitted
- 9 Mar 2012
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation as a Novel Therapeutic Approach in Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT01569958
- Acronym / sponsor ID
- TDCS2011-01
- Conditions
- Amyotrophic Lateral Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Università degli Studi 'G. d'Annunzio' Chieti e PescaraUniversity, hospital or other
- Collaborators
- Catholic University, Italy, Federico II University, Ministero della Salute, Italy
- Study start
- Jul 2012
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 3 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disease characterized by progressive weakness and muscular atrophy due to the degeneration and loss of motor neurons, the nerve cells that, in the central nervous system (motor cortex, brainstem and spinal chord), control voluntary movement. Riluzole, the only drug approved for ALS treatment, modestly slow disease progression.
Transcranial direct current stimulation (tDCS) is a noninvasive technique of neuromodulation that is currently studied as a possible therapeutic tool for several neurological and psychiatric diseases and has been found safe and well tolerated. Based on experimental evidence in animals and human subjects, tDCS is expected to reduce motor cortex excitability and excitotoxicity, that is neuronal injury induced by excessive glutamatergic stimulation, one of postulated pathophysiological mechanisms in ALS.
This study will investigate if transcranial direct current stimulation of motor cortex is useful in delaying disease progression and is well tolerated in ALS patients.
Detailed description
This is a double blind, randomized, placebo-controlled clinical trial.
Cathodic tDCS (1 mA for 20 minutes) will be sequentially applied over the motor cortex of both sides, for five consecutive days every month for twelve months. The control group will receive a sham stimulation that reproduce tactile sensation of real stimulation but has no effects on central nervous system. For stimulation, researchers will employ a CE-certified medical device acting as a micro-processor-controlled constant current source. All patients will take riluzole during the entire period of the study.
Fifty-four participants will be recruited from three Italian Centers and randomized to one of two arms of the study.
Disease progression and quality of life will be evaluated at baseline and every three months during the study.
At each visit adverse events will be reported and tolerability will be assessed through a specific questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS | Active comparator | Other: transcranial direct current stimulation |
| sham | Sham comparator | Other: Sham stimulation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- diagnosis of probable, laboratory-supported probable, or definite amyotrophic lateral sclerosis according to the El Escorial revised criteria
- spinal onset
- aged 18 to 85 years inclusive
- disease duration ≤ 24 months
- disease progression in the past 3 months
Key exclusion criteria (9 listed)
- bulbar onset
- previous poliomyelitis
- motor neuron diseases other than ALS
- clinical involvement of other neurological systems
- pregnancy, lactation,or unwillingness to contraception if required
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulationtranscranial direct current stimulation applied to the motor cortex of both sides (1 mA, 20 minutes) for five consecutive days every month for 12 months | Other | tDCS |
| Sham stimulation1 mA stimulation for 30 seconds every 900 seconds per session | Other | sham |
Primary outcome
Decline of ALSFRS-R (ALS functional rating scale-revised) from baseline to 12 months
Time frame: 12 months
4 secondary outcomes
Decline of muscle strength from baseline to 12 months
Time frame: 12 months
Change of upper motor neuron signs from baseline to 12 months
Time frame: 12 months
Decline of forced vital capacity (percent of predicted normal) from baseline to 12 months
Time frame: 12 months
Change of quality of life from baseline to 12 months
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Centro Regionale Malattie Neuromuscolari, Ospedale Clinicizzato "SS. Annunziata"
Chieti, Italy
Alessandra Lugaresi, MD, PhD principal investigator
Università "G. d'Annunzio" di Chieti e Pescara, Dipartimento Neuroscienze ed Imaging, and ASL n. 2 Lanciano-Vasto-Chieti
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing transcranial direct current stimulation in people with Amyotrophic Lateral Sclerosis, run by Università degli Studi 'G. d'Annunzio' Chieti e Pescara at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decline of ALSFRS-R (ALS functional rating scale-revised) from baseline to 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2012.